check_circleStudy Completed

Hyperphosphatemia

Bayer Identifier:

15077

ClinicalTrials.gov Identifier:

NCT01419327

EudraCT Number:

Not Available

EU CT Number:

Not Available
Fosrenol post-marketing surveillance for hemodialysis in Japan

Trial purpose

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in hemodialysis who received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. A total 3,000 patients will be recruited and followed 5 years.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia
  • - Patients who are contraindicated based on the product label

Trial summary

Enrollment Goal
3267
Trial Dates
March 2009 - May 2019
Phase
N/A
Could I Receive a placebo
No
Products
Fosrenol (Lanthanum Carbonate, BAY77-1931)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Incidence of adverse drug reactions in subjects who received Fosrenol
    date_rangeTime Frame:
    After Fosrenol administration, up to 8 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Timing of onset of common ADRs related to the priority survey items
    The items are - Gastrointestinal symptoms - Secondary hyperparathyroidism - Hypocalcaemia and decreased blood calcium
    date_rangeTime Frame:
    After Fosrenol administration, up to 8 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Effect on bones: Alkaline phosphatase over time
    date_rangeTime Frame:
    After Fosrenol administration, up to 8 years
    enhanced_encryption
    Safety Issue:
    No
  • Effect on bones: Change in bone density
    date_rangeTime Frame:
    After Fosrenol administration, up to 8 years
    enhanced_encryption
    Safety Issue:
    No
  • Cardiothoracic ratio over time
    date_rangeTime Frame:
    After Fosrenol administration, up to 8 years
    enhanced_encryption
    Safety Issue:
    No
  • PWV and ABI over time
    date_rangeTime Frame:
    After Fosrenol administration, up to 8 years
    enhanced_encryption
    Safety Issue:
    No
  • Serum P, albumin-corrected serum Ca and serum intact PTH, and Ca-P product over time
    date_rangeTime Frame:
    After Fosrenol administration, up to 8 years
  • Percentage of patients achieving the serum P control goal
    date_rangeTime Frame:
    After Fosrenol administration, up to 8 years

Trial design

Special drug use investigation of Fosrenol (long-term investigation for patients with hemodialysis)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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